One more item for everyone. If FDA approves, this means Kempharm must meet expensive post-marketing commitments. But, if there's no abuse-deterrence label, it won't sell, according to Kempharm, so in this case approval may not even be preferable.
Almost certain it is procedural. The federal regs say that without a label the FDA approves, it has to issue a CRL.
We are not going to be waiting very long for this meeting. It takes about 2 months... 1 month to prepare documents and one month to schedule. CRL only related to labels imo, nothing else.
No label is exactly the same as no approval. They can't sell without AD label. This is a massive massive overreaction. I think the CRL is procedural in nature and relating to timing issues.
I think that the company is factoring in stricter FDA standards in 2016, which might be caused more by undertones of political concerns than anything else.
What is your take on overall management quality? Is this another CMRX?
Well, "jillbloes", I have this to say:
1) Yes, one member did mention it. You have selective memory. Remind me again in two weeks and I'll point out the exact point in the webcast.
2) Take an anger management class. Is there a point to embarassing you when you spout off like that?
3) People can die from taking naltrexone right after oxycodone because of the sudden withdrawal.
There is, according to what I have read. I don't know if it exists in an IR formulation, but definitely an ER formulation. You get sudden withdrawal and could die by taking a bunch of naltrexone right after you take oxycodone.
The prodrug is KP201, but the product is KP201/APAP. It may be that the FDA is more interested in having KP201 as a replacement for just hydrocodone, which does demonstrate much larger differences in liking through the nasal route of abuse. Hydrocodone is much more abusable than Hydrocodone/acetaminophen, except when the hydrocodone is removed from hydrocodone/acetaminophen with just water, so the FDA is really contradictory here.
I think we need clarity as to what the FDA thinks about the current drug as of this moment. Kempharm says they've been in productive discussions with the FDA, but what does that mean? Investors need more information.
Totally. But some might also die. As meifud pointed out, Elite's drug won't have as high a concentration since it's an IR drug. I'm just pointing out some apparent inconsistency with the FDA and adcomm here. They want to save people from dying by approving a drug (Pfizer's drug) that may actually kill more people.
I mis-typed that. Max is 90 days under major amendment.